Posted by Michael Wonder on 25 Oct 2022
IntelGenx receives FDA GDUFA date for Xiromed partnered development candidate, buprenorphine buccal film
25 October 2022 - IntelGenx today announced that its previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated new drug application has been filed by Chemo Research through its agent and affiliate Xiromed, has received a US FDA Generic Drug User Fee Act date of 28 April 2023.
Buprenorphine buccal film is a generic version of Belbuca, an opioid that is used to manage pain severe enough to require daily, around the clock, long-term treatment with an opioid, when other pain treatments are inadequate.
